A Pharmacokinetic Study of Minocycline in Male and Female Volunteers

NCT02250859 | Completed Phase 1

• 1 other identifier: FMX101-1
• Study Type: interventional
• Target: 12
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to assess the pharmakokinetic profile of Minocycline in FMX-101 4% foam product in male and female some of which are with acne

Conditions

Acne

Outcome Measures

Primary Outcomes (7)

• adverse events

  AEs will be assessed starting from informed consent signature until end of study)

  22-25 days

• irritation and local reaction

  The application area will be examined for irritation and local reaction

  16 days

• Change from baseline in vital signs

  sitting BP, HR, RR, oral temperature

  22-25 days

• Cmax

  will be assessed after 1 and 16 days of dosing

  16 days

• Tmax

  will be assessed after 1 and 16 days of dosing

  16 days

• AUCT

  will be assessed after 1 and 16 days of dosing

  16 days

• T½

  will be assessed after 1 and 16 days of dosing

  16 days

Study Arms (1)

FMX101 Minocycline 4% foam

EXPERIMENTAL

FMX101, 4% applied to the face, upper chest, upper back and shoulders for sixsteen consecutive days in subjects either with acne or with normal skin

Drug: FMX101, Minocycline 4% foam

Interventions

FMX101, Minocycline 4% foam DRUG

FMX101, Minocycline 4% foam to be applied twice daily for 16 consecutive days

Also known as: FMX101 antibiotic foam

FMX101 Minocycline 4% foam

Eligibility Criteria

• Age: 18 Years - 35 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Men and women between 18 and 35 years (inclusive) of age.
• Clear skin or facial acne of any severity, currently untreated
• Otherwise healthy subjects
• Subjects who provide written informed consent to participate in the study.
• Women of childbearing potential who are willing to use 2 reliable methods of contraception or practice abstinence during the study period or be surgically sterilized and agree to undergo repeated pregnancy tests.
• Body Mass Index (BMI) 19.0 to \<30.0 kg/m2 and weight ranging between 60-90 kg (males) and 50-85 (females).
• Non-smoking and no use of any tobacco or nicotine products (by declaration) for a period of at least 6 months prior to screening visit
• Subjects in general good health in the opinion of the investigator as determined by medical history, vital signs, ECG and a physical examination.
• Shaven facial hair (males)
• Negative HIV, Hepatitis B and Hepatitis C serology tests at screening.
• No clinically significant abnormalities in hematology, blood chemistry, or urinalysis lab tests at screening.
• No known history of alcohol or drug abuse. Negative urinary screen for drugs of abuse determined within 21 days of the start of the study (screening visit).
• Willingness to minimize exposure to sun for 20 days after first dosing
• Subjects must be able to understand the requirements of the study and must be willing to comply with the requirements of the study

You may not qualify if:

• Documented history or ongoing symptoms of significant neurological, renal, cardiovascular, respiratory (asthma), endocrinological, gastrointestinal, hematopoietic disease, neoplasm or any other clinically significant medical disorder, which in the investigator's judgment contraindicate administration of the study medications.
• Known or suspected pregnancy or lactation or planned pregnancy during the study duration (females)
• Use of topical antibiotics or topical corticosteroids for acne treatment within the past 2 weeks.
• Use of systemic corticosteroids within the past 4 weeks.
• Use of systemic retinoids (e.g. isotretinoin) within the past 6 months.
• Concurrent use of medications known to be photosensitizers because of the possibility of augmented photosensitivity.
• History or evidence of skin conditions other than acne (eg, eczema) that would interfere with the subject's participation in the study.
• Use of any prescription or over-the-counter (OTC) medications, vitamins and herbal or dietary supplements within 14 days prior to dosing. Paracetamol or ibuprofen for symptomatic relief of pain is allowed until 24 hours prior to the study drug administration.
• Dermatological conditions which might have an effect upon dermal application, e.g.: Psoriasis, mycosis fungoides, widespread acne, facial or back dermatophytosis, severe hyperhydrosis, chronic or recurrent skin infections, ichtyosis
• Excessive hair in the intended application areas
• Current or recent (within 1year) drug or alcohol abuse.
• Known contraindication, hypersensitivity and/or allergy to the study drug or its excipients.
• Subjects with significant allergic response to other drugs
• Any acute illness (e.g. acute infection) within 48 hours prior to the first study drug administration, which is considered of significance by the Principal Investigator.
• Participation in another clinical trial with drugs received within 3 months prior to dosing (calculated from the previous study's last dosing date).

Sponsors & Collaborators

• Vyne Therapeutics Inc.: lead

Study Sites (1)

Sourasky Medical Center, Clinical Research Center

Tel Aviv, Israel

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Minocycline

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Tetracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Officials

• Jacob Atsmon, MD

  Sourasky Medical center, Tel-aviv, Israel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 21, 2014
• First Posted: September 26, 2014
• Study Start: September 1, 2014
• Primary Completion: December 1, 2014
• Study Completion: January 1, 2015
• Last Updated: February 25, 2021

Record last verified: 2021-02

Locations

IL (1)